Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China

• Conditions: Healthy volunteers: active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (such as meningitis, septicaemia, cellulitis, arthritis, epiglottitis, pneumopathy, osteomyelitis); MedDRA version: 18.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005404-29-Outside-EU/EEA
• Lead Sponsor: SANOFI PASTEUR SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-04
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
1) Aged 2 months (60 to 74 days) inclusive on the day of the first study visit
2) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
3) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 900
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
1) Participation or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
2) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
3) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
4) Clinically significant illness, according to investigator judgment, at a stage that could interfere with trial conduct or completion
5) Evolving encephalopathy
6) Receipt of immune globulins, blood or blood–derived products since birth
7) Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection
8) Receipt of any other vaccine in the 14 days preceding the first trial vaccination or planned receipt of any vaccine in the 14 days following the first trial vaccination
9) Acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature =37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
10) Contraindications to vaccination according to PENTAXIM® summary of product characteristics (SPC) or leaflet
11) In an emergency setting, or hospitalized involuntarily
12) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified